Pain, Chronic Clinical Trial
— BURSTOfficial title:
A Prospective Single-arm, Multi-center Clinical Study Examining the Changes in Quality of Life and Pain Following Dorsal Root Ganglion Stimulation for the Treatment of Chronic Intractable Pelvic and Lower Limb Pain
Verified date | March 2020 |
Source | KM Clinical Research Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Study Title Subject-reported treatment efficacy and procedure satisfaction (steps) study.BURST study- a prospective observational clinical study examining the changes in quality of life and pain following spinal cord stimulation for the treatment of chronic intractable lower back and lower limb pain.
Status | Terminated |
Enrollment | 26 |
Est. completion date | February 1, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: Prescribed spinal cord stimulator implant by their healthcare provider. Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief. Willing and able to adhere to the protocol of the study including the survey timeline. Between the ages of 18-85 years. Exclusion Criteria: Unwilling to sign Informed Consent and comply with protocol |
Country | Name | City | State |
---|---|---|---|
United States | KM Clinical Research Group | Murrieta | California |
Lead Sponsor | Collaborator |
---|---|
KM Clinical Research Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pain Levels | Change in self-reported pain levels | 12 months post-permanent spinal cord stimulator implantation | |
Primary | Change in quality of life | change in self-reported quality of life | 12 months post-permanent spinal cord stimulator implantation | |
Secondary | Change in prescription pain medication use | change in opioid medication use to control pain | 12 months post-permanent spinal cord stimulator implantation |
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